Securement devices are used in the medical profession to secure needles, catheters, and catheters with extension sets inserted within patients to prevent dislodgement, phlebitis, damage to surrounding tissue, and the ingress of bacteria at the insertion site. Medical grade tape can be used as a securement device or to supplement a securement device. Safe and effective securement devices are particularly critical for the treatment of chronic conditions, such as kidney failure, which requires frequent dialysis treatment for removing waste from a patient's blood. For a patient receiving routine hemodialysis, for example, a temporary access catheter is one method that may be used to gain access to the blood. Catheter access consists of a catheter with two lumens which is inserted into a large vein to allow large flows of blood to be withdrawn from one lumen, to enter the dialysis circuit, and to be returned via the other lumen. In another method of dialysis, peritoneal dialysis, a patient has a surgically inserted catheter that then is attached to an extension set. That patient infuses a dextrose solution into their peritoneal sac and the peritoneal membrane allows for osmotic removal into the dextrose solution, which provides normal kidney function to occur.
To expedite hemodialysis which can take hours to complete, efficient blood and dialysate flow rates are desired. To achieve optimal flow rates, needles or catheters often require adjustment, either at the onset of or at some point during treatment. Typically, to adjust a securement device, tape is removed and new tape is applied to and around the site further aggravating the skin.
Healthcare providers have struggled with providing securement devices that are effective and sterile yet minimally aggravating to patients.
Expired U.S. Pat. No. 4,702,736 (Kalt I) discloses a clamp for holding an article to an object including a base means for adhering the clamp to the object, a flap, securing means for securing the flap to the base means with the article positioned there between and resilient pad means having an adhesive surface for contacting the article. The securing means includes a first holding means for holding a first portion of the flap and a second holding means for holding a second portion of the flap. Both holding means may be releasable. The second holding means is spaced from the first holding means a sufficient distance along the flap for the article to lie between them. Resilient adhesive surfaces are provided on the flap and base means for contacting and adhering the article. However, the Kalt I reference discloses one continuous piece as a bottom base which can still potentially cause movement and discomfort near the insertion site.
Expired U.S. Pat. No. 4,738,662 (Kalt II) discloses a clamp similar to that of Kalt I, but adds a second clamp for holding an article to an object including a bottom base means for adhering the clamp to an object, a top flap with a slit, a resilient adhesive pad, and securing means for securing the flap to the base means with the article passing through the slit in the flap and perpendicular to the base. The securing means includes a first holding means and a second holding means for holding the top flap and bottom base. Both holding means may be releasable. The clamp comprises a top flap with a slit to create two sections of the first portion of the securing means, one section on each side of the slit. The second holding means is on the bottom base. The first and second holding means are removably connected. The slit allows an object to pass through the clamp where it will adhesively connect to a resilient adhesive pad located on the top flap. Kalt II discloses that, in the preferred embodiment, the slit provides stability for a tube upon exiting the nasal passage way to extend upward along the bridge of the nose. The Kalt II reference discloses a second clamp to be used in combination with the Kalt I reference. However, the second clamp disclosed in the Kalt II reference introduces a slit to allow the tube to pass directly through the flap in order to extend upwardly.
There is a long-felt need for a for a securement device that can easily attach and secure needles, catheters, and catheters with extension sets inserted within a patient to prevent damage to surrounding tissue, dislodgment, and infection at the insertion site.
Therefore, there is a long-felt need for a securement device for securing medical devices to patients that connects the bottom of the flap when folded over, now on top, to the base in order to provide a high level of stability and create the least amount of stress near an insertion site.